Health Technology Assessment (HTA), Joint Clinical Assessment (JCA) and market access consulting for medical devices, IVDs and digital health technologies, built around EU HTA Regulation.

When you need it
Payers ask why they should fund your technology instead of what they already use. The answer has to hold in every market you enter, and the requirements differ. The clinical half of that answer is now given once at EU level, where a Joint Clinical Assessment applies.

What you get
A systematic evaluation of clinical and economic value built to EU HTA Regulation 2021/2282, covering the clinical, economic, organisational, social and ethical domains as one consistent argument. Where a JCA applies, we build the submission around the consolidated PICOs. You are ready for market access from day one, not collecting evidence after launch.

How it works

1. We map the HTA requirements of your target markets and identify what evidence you already have.


2. Our health economics, regulatory and business modelling teams assemble what is missing.


3. You get a submission-ready dossier and the model behind it, for a national payer, for a JCA, or both.

Cost-effectiveness, cost-utility and budget impact modelling for health economics, HEOR and market access teams.

When you need it
Pricing negotiations are coming, and in that room opinions lose and numbers win.

What you get
Models built on data payers already accept, with transparent assumptions and sensitivity analysis, so you walk in knowing your price is defensible:
• Cost-effectiveness, cost-utility and cost-benefit analyses
• Budget impact models
• Cost-consequence analyses
• Asset valuation and value-based pricing models

How it works

1. We agree what decision the model has to support and who will challenge it.


2. We recommend the methodology that fits the objective, not the one that is easiest to build.


3. We build, validate and document the model, then walk your team through the results.

Cost-benefit analysis (CBA) that puts a defensible value on social, environmental and quality-of-life impact.

When you need it
Your project affects several groups at once: patients, providers, a municipality, an insurer. The benefits that matter most are not financial ones.

What you get
A cost-benefit analysis that puts a defensible financial value on qualitative effects i.e. social, environmental, quality of life alongside hard costs, so the whole impact can be compared in one framework and presented to the people who control the budget.

How it works

1. We identify every actor the decision touches.


2. We map the positive and negative impacts on each of them.


3. We select a valuation method and convert qualitative benefits into financial values.


4. You get scenarios you can weigh against each other and defend to stakeholders.

Budget impact modelling that shows payers, insurers and health systems exactly what your technology costs — and saves — over time.

When you need it
“We cannot afford it” ends more deals than any clinical objection.

What you get
A quantified answer: what adopting your technology does to a payer’s budget, line by line and year by year. It is built on incidence, prevalence and real utilisation data, with sensitivity analysis on the assumptions that matter most.

How it works

1. We define the target population from incidence, prevalence and the size of the treated group.


2. We quantify resource use e.g. hospitalisations, outpatient care and the associated costs.


3. We model the current pathway against the pathway with your technology in it.


4. You get the annual budget impact, with every assumption visible and adjustable.

Business modelling and commercialisation strategy for new medical technologies, from market sizing to investor-ready valuation.

When you need it
Investors ask the hard questions on the day you are least ready for them: who pays, how much, and what is the company worth if they do.

What you get
• An adoption analysis showing how users, patients, public authorities and institutional management respond to the technology
• Market size, customer profile, willingness to pay and a review of active competitors
• A quantified business model and cash-flow model producing valuation scenarios
• A commercialisation route, including IP and licensing options

How it works

1. We survey your target groups with a purpose-built questionnaire to model the real market situation.


2. We capture the business idea in a Business Model Canvas and turn it into a system dynamics model.


3. The model pressure-tests your go-to-market and produces valuation scenarios under founder and investor assumptions. This provides you opportunity to change course before it is too late.

Literature Review & Meta-Analysis

Systematic literature reviews and meta-analyses for HTA submissions, economic models and clinical evidence generation.

When you need it
Every claim you make will be challenged either by a payer, a reviewer or a notified body.

What you get
Publication-grade evidence with a documented protocol and search strategy, so the challenge ends there:
• Epidemiologic, humanistic and economic burden of a disease
• Treatment guidelines and patterns in clinical practice
• Clinical and cost-effectiveness of comparator treatments
• Best practices in economic modelling for the disease area
• Model inputs including resource use, cost and utility estimates

How it works

1. We define the research question and fix the protocol before the search begins.


2. We run and document the search, then screen and extract the evidence.


3. We synthesise the findings and deliver them as model input, HTA evidence or a manuscript.

Regulatory affairs and medical device compliance consulting for CE marking under EU MDR and IVDR.

When you need it
You are bringing a device or diagnostic to market and a rejected technical file would cost months you do not have.

What you get
One partner for the whole conformity assessment process:
• Regulatory strategy and CE mark of conformity
• Technical documentation and compliance
• ISO 13485 quality management system
• Cybersecurity compliance

Together with the economic and social impact evidence that convinces investors, payers and funding bodies, from the same team. Your compliance file and your economic case will tell the same story.

How it works

1. We run a gap analysis of where you stand against where the regulation requires you to be.


2. We design the individual steps, including the tests and verifications needed.


3. We execute alongside your team and guide you through the communication with notified bodies.

Regulatory strategy and CE marking consultancy for EU MDR (EU) 2017/745, IVDR and FDA market entry.

When you need it
Picking the wrong route can cost you a year — and you do not yet know which route applies, which notified body to approach, or what it will take before you start.

What you get
A written regulatory strategy: device classification, the applicable conformity assessment route, the realistic options with their time and evidence implications, and coverage across EU MDR (EU) 2017/745, FDA guidelines and further target markets. The shortest legitimate path to market, mapped before you commit.

How it works

1. We analyse your device and its intended purpose to establish classification.


2. We map the available routes and recommend the one that fits your timeline and resources.


3. We guide you through the communication with notified body during the conformity assessment.

Technical documentation consulting for GSPR, MDCG guidance, ISO 14971 and notified body submissions.

When you need it
Auditors know exactly where to look first. On the other hand you are not certain what is missing, or a notified body has already come back with findings.

What you get
A technical file prepared to the standards auditors check, and defended when they ask any of these:
• Usability analysis (IEC 62366-1) and risk analysis (ISO 14971)
• Pre-clinical and biological evaluation (ISO 10993-1) and technical safety (IEC 60601-1)
• Software documentation (IEC 62304) and user manuals
• Clinical evaluation, post-market clinical follow-up and vigilance
Plus a full assessment of your testing needs i.e. electrical, biological and clinical. This will give you guidance for retesting as standards evolve as well.

How it works

1. We audit your existing documentation against GSPR, international standards and MDCG guidance, and list the gaps.


2. We prepare or revise each document to close them.


3. We define the testing plan and keep the file current as the standards change.

ISO 13485 quality management system (QMS) implementation and certification support for medical device manufacturers.

When you need it
A generic ISO 13485 template slows your team down every single day it exists — whether you are building a QMS for the first time or already living with one that does not fit.

What you get
A quality management system built around how your people actually work, so quality stops being a tax on development and starts protecting it — fully aligned with ISO 13485 and ready for the certification audit.

How it works

1. We start with individual interviews to map how the work is really done today.


2. We design processes that fit that reality and meet the standard.


3. We optimise for efficiency, not just compliance, and prepare you for certification.

Cybersecurity compliance consulting for the Cyber Resilience Act (CRA) and IEC 62443 series.

When you need it
The Cyber Resilience Act and the IEC 62443 series will stop products that are not ready — and nobody in the company can yet say which requirements actually apply to yours.

What you get
A readiness assessment today costs a fraction of a redesign later, and keeps a launch date from slipping:
• Readiness pre-assessment and gap analysis against CRA and IEC 62443
• Interpretation of the requirements that genuinely apply to your product
• Secure development lifecycle guidance and vulnerability management support
• Product security requirements management, with traceability between risks, controls and testing activities
• Recommendations for governance and responsibility frameworks

How it works

1. We establish which requirements apply and assess your current state against them.


2. We translate them into internal processes your teams can actually run.


3. We prepare you for assessments, audits and certification — as an independent advisor connecting management, engineering, quality and regulatory teams.

Not generic documentation, but a robust, auditable approach tailored to your product and business environment.

AI Act and European Health Data Space (EHDS) compliance for AI-enabled medical devices and digital health.

When you need it
Your algorithm now sits under three regimes at once: MDR or IVDR for the device, the AI Act for the model, EHDS for the data behind it. Few teams can say which obligations are already live.

What you get
One integrated file instead of three parallel projects. The AI Act (Regulation (EU) 2024/1689) lets a high-risk AI system already under MDR or IVDR be assessed together with it: classification, gap analysis, data governance for your training sets, and EHDS readiness under Regulation (EU) 2025/327. EHDS secondary use also opens real-world data, which the same team turns into your economic case.

How it works

1. We establish which regimes apply and when each obligation bites.


2. We assess your documentation, data pipeline and quality system against all of them.


3. We merge the AI Act into the file you already maintain, so one process serves them all.

Regulatory compliance for food, supplement and borderline products — from classification to health claims and labelling.

When you need it
One wrong health claim can pull a product off the shelf . You are launching a food, functional or borderline product without certainty about how it will be classified.

What you get
Classification, claims, labelling, novel foods and HACCP sorted out before an authority does it for you:
• A classification opinion and confirmation of the applicable regime
• An assessment of your health claims against what is permitted
• A labelling compliance review and adaptation of your communications
• Novel food and market entry requirements, plus HACCP support
• Documentation prepared for the authorities

How it works

1. We classify the product and confirm which regulatory regime applies.


2. We check claims and labelling against what the regulation allows, and identify the gaps.


3. We prepare the documentation and adapt the communication, so the product stays commercially compelling and regulatorily defensible.

Regulatory and health economics consulting for CBRN medical countermeasures and defence programmes.

When you need it
Defence and preparedness buyers ask different questions and follow different rules. You are developing countermeasures or protective equipment, or entering a programme that demands both regulatory and economic expertise.

What you get
• Regulatory pathways for CBRN medical countermeasures, including antidotes, autoinjectors, decontamination products and protective equipment
• Applied health economics and cost-benefit analysis for defence and security products
• Market access and marketability assessment for defence markets
• Support for Horizon Europe projects requiring regulatory and economic expertise in CBRN and defence

How it works

1. We clarify product classification and the regulatory route across the relevant threat categories.


2. We build the regulatory and economic evidence in parallel, so neither becomes the bottleneck.


3. We support the tender or grant requirements you have to meet. It comes from a team that already works within these programmes.